MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA QUAD XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1Q1

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293)

Patient Problems Atrial Flutter (1730); Weakness (2145); Palpitations (2467); Shock from Patient Lead(s) (3162)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 429888 lead, implanted (b)(6) 2015.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency room with palpitations and weakness.The patient had received two inappropriate shocks.It was found that the patient was in atrial flutter with rapid ventricular response and had received the shocks due to misinterpretation of ventricular tachycardia.The patient was admitted and underwent a transesophageal echocardiography and cardioversion.The device remains in use.The patient is a participant in the (b)(4).No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was also reported that the device was reprogrammed after the procedure.

• Brand Name: VIVA QUAD XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6318241
• MDR Text Key: 67099440
• Report Number: 3004209178-2017-03192
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169018013
• UDI-Public: 00643169018013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2016
• Device Model Number: DTBA1Q1
• Device Catalogue Number: DTBA1Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: 11/17/2016; 09/09/2017
• Supplement Dates FDA Received: 09/14/2017; 12/07/2017
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 694765 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 70